A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (NCT06996782) | Clinical Trial Compass
RecruitingPhase 1/2
A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
United States152 participantsStarted 2025-11-24
Plain-language summary
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
* Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.
* Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
* Minimum life expectancy of 12 weeks in the opinion of the investigator.
* Adequate organ and marrow function.
* Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Adequate organ and marrow function.
Inclusion Criteria for Sub Study 2:
* Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report).
* Adequate coagulation and urinalysis.
* Minimum body weight of 30 kg.
Exclusion Criteria:
* Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of care.
* Presence of small cell and neuroendocrine histology components.
* Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease/pneumonitis (of any grade); unstable and/or symptomatic …
What they're measuring
1
Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Approximately 46 months
2
Part A: Number of partcipants with dose limiting toxicity (DLT)